Event Archives

Event Name Event Description Event Dates Event Location

Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations (public workshop)

Date: July 17, 2019 – 8:30 am to 4:00 pm
Location: Marriott Marquis Washington, DC (Liberty Salons MNOP)

FDA is seeking feedback from stakeholders on the challenges, barriers, and enablers that might be impacting the adoption of RBM, and related opportunities to improve RBM implementation. This public workshop, held under a cooperative agreement with the U.S. Food and Drug Administration, is an opportunity to capture stakeholder input on:

  • The extent to which organizations have implemented risk-based assessment and monitoring, including in conjunction with central monitoring approaches
  • Lessons learned from strategies employed to overcome any obstacles to implementation and to continued execution of RBM
  • Enablers that support implementation and execution of risk-based monitoring
  • How stakeholders assess impact of their RBM program
  • Remaining challenges to implementation or execution that need to be addressed

Session 5: Measuring the Impact of Risk-Based Monitoring Approaches
Session 6: Synthesis and Next Steps

Session Participant: Linda B Sullivan, Executive Director WCG-Metrics Champion Consortium

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Washington, DC

DIA Annual Meeting

Date: Tuesday, June 25 • 10:30am – 11:30am
Location: San Diego, CA

Session Title: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring
Session Information: This session will explore new approaches to quality risk management implemented by stakeholders since the adoption of ICH E6 (R2) and the vital role of critical thinking and metrics in bridging from risk assessment to centralized monitoring.

Moderator: Linda B Sullivan, MBA Executive Director, Metrics Champion Consortium

Suzanne Lukac
Senior Account Director, CluePoints

Ann McCabe
Director, Process Excellence and Risk Management, Daiichi Sankyo Inc

Sherry Merrifield
Senior Director, Global Operations Management, Syneos Health


San Diego, CA

European Clinical Trials Inspection Readiness Summit

Date: May 16–17, 2019
Location: London, UK

Session Title: Building the Gap Between CAPA and Quality Risk Management to Prevent Systemic-Level Issues

Session Information:

  • Examine the link between sections 5.0 (Quality Management) and 5.20.1 (Noncompliances) in ICH E6 (R2)
  • Explore toolkits developed by an industry consortium that support Quality Risk Management and align with inspector expectations
  • Discuss the importance of documentation of Quality Management decisions and actions for inspection readiness and approaches to achieve this

Session Participation: Keith Dorricott, Ambassador, Metrics Champion Consortium


London, UK

Clinical Trial Innovation Summit

Date: May 13–15, 2019
Location: Boston, MA

Session Title: Connecting CAPA Preventative Actions to Quality Risk Management to Reduce Systemic-Level Risks on New and Ongoing Studies

Session Information:

  • Explore the link between sections 5.0 (Quality Management) and 5.20.1 (Noncompliances) in ICH E6 (R2)
  • Discuss the importance of documentation of CAPA Action Plans and Quality Management decisions and actions
  • Describe resources developed by an industry consortium that support CAPA Management and Quality Risk Management

Session Participation: Linda B Sullivan MBA Executive Director, Metrics Champion Consortium


Session Title: Using Site Contracting Performance Metrics in Site Selection—Do You Have Access to the Right Data to Understand How the Site Performed?

Session Information:

  • Explore why site contracting cycle times vary by country
  • Discuss approaches organizations are using to reduce cycle time results
  • Review the data your organization should be reviewing to gain insights about which sites perform well in the context of local regulatory and ethical review requirements

Session Participation: Linda B Sullivan MBA Executive Director, Metrics Champion Consortium


Boston, MA

Evolution Summit Spring 2019 (Invitation only event)

The Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.

Date: February 24–26 2019
Location: The Ritz-Carlton Rancho Mirage, CA

Session Title: The A-Z of Risk-Based Monitoring (RBM): Strategies for the Future

Session Information: As the clinical trials industry continuously evolves, novel strategies must be implemented in an effort to operate efficiently and ultimately accelerate drugs to market. A more centralized, risk-based approach to site monitoring has presented itself as one viable method of reducing costs. Although RBM has been buzzing in the industry for quite some time, its adaptation has been slow. This presentation will shed light on:

  • Implementing a well-designed RBM strategy that enhances, whilst supporting, traditional monitoring approaches
  • Tools needed to execute the strategy
  • Overcoming challenges and the benefits to be realized

Session Participation: Linda B. Sullivan, Executive Director, Metrics Champion Consortium

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Rancho Mirage, CA

SCOPE – Summit for Clinical Ops Executives 2019

Date: Tuesday, February 19, 2019 (4:15–5:00 PM)

Interactive Breakout Discussions:
Vendor Performance Metrics and KPIs

  • How effective are your KPIs for measuring vendor performance and quality?
  • What is your strategy for establishing KPIs and metrics? Who are the stakeholders developing performance metrics?
  • What are the key areas that should be evaluated for vendor performance and quality?

Participation: Moderator – Linda B. Sullivan, Executive Director, Metrics Champion Consortium


Date: Wednesday, February 20, 2019 (8:55 AM)

Track: Mastering an Outsourcing Strategy

Panel Discussion: Ensuring Harmony between All Stakeholders – Sponsor, CRO, and Site – When Site Sourcing

Topics to be discussed: Working with stakeholders on setting appropriate site budgets, site contracting, site identification, selection of sites, and site oversight/ management

Moderator: Ly Kawaguchi, Senior Director, DBO-Outsourcing, Site Budgets, and Business Analytics, MyoKardia, Inc.

Panelists: Jennifer Trevor, Ph.D., Sr. Portfolio Sourcing Manager, Portfolio Sourcing and Relationship Management, Astellas Pharma
Carlos Orantes, CEO, Accel Research Sites
Linda Sullivan, CO-Founder & Executive Director, Metrics Champion Consortium

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Orlando, FL

ICH E6 GCP Interactive Workshop – How to Build A Sponsor Risk Management Program

Presented by FDAnews and Technical Resources International Inc.
Tuesday-Wednesday December 11-12, 2018 • Raleigh, NC

For clinical trials, it’s a new ball game. The ICH E6 (R2) guidelines now require trial sponsors to institute risk assessment at both the system and clinical trial levels; and require drug and biologics makers to qualify vendors.

Trial sponsors now must institute risk assessment at both the system and clinical-trial levels. Have you established your program yet? Is your maintenance program complete? If not, this hands-on, interactive workshop is just the ticket. Prepare to discover:

  • What the new guidelines require
  • How to establish your program step-by-step
  • Critical elements of starting your program: A walk-through
  • How to conduct risk assessment at both system and clinical-trial levels
  • Evaluating the risks: Your options
  • Risk mitigation and reporting strategies
  • Common pitfalls and how to sidestep them
  • And much more!

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Raleigh, NC

Clinical Trial Risk and Performance Management Summit

A Metrics Champion Consortium/CenterWatch Event
Wednesday–Thursday November 14-15, 2018 • Princeton, NJ

Come to Princeton Nov. 14 and 15 for the first-ever Metrics Champion Consortium Summit. This will be an exclusive gathering of the top minds in trial performance metrics, spearheaded by MCC Executive Director Linda Sullivan. Our keynote speaker will be Ken Getz, Associate Professor and Director, CSDD, Tufts University and Founder and Board Chair, CISCRP, clinical trials guru, founder of CenterWatch and an MCC partner. Linda and Ken and our roster of experts will guide you through the issues that are top of mind in clinical trials metrics today:

  • How is ICH-E6(R2) changing what you need to measure? What are global regulators looking for?
  • How do metrics influence behavior? Are you rewarding firefighting or preventing problems? Does your staff have the critical thinking skills needed to root out what needs to be changed?
  • Centralized monitoring. How is industry approaching key risk indicators and quality tolerance limits?
  • Getting to the root of the problem. Pros and cons of traditional analytic approaches: Is there a better way?
  • Predictive analytics. The next-level key to your success. But how do you get there?

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Princeton, NJ

Institute of Clinical Research—Project Management Forum

Thursday October 19, 2018 • Farnborough in the UK

Presenter: Keith Dorricott
Director, Dorricott Metrics & Process Improvement Ltd,
MCC Ambassador

Presentation Topic: “Risk Assessment in the era of ICH E6 (R2): Building on the TransCelerate Risk Assessment and Categorization Tool (RACT)”

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Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Mark your calendar for Thursday, Oct. 18, when Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd, will discuss approaches sponsors are taking to align with ICH E6(R2).

During 60 fast-paced minutes Linda and Keith will:

  • Explore new risk-based quality management requirements described in ICH E6(R2) section 5.0
  • Discuss the importance of critical thinking in risk assessment and risk control
  • Explain the meaning of high and low detectability and the relevance to risk prioritization
  • Describe leading practices to improve risk assessment and quality oversight

Learn more.


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